A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage I Colon Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This pilot clinical trial studies the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help decrease the chance of cancer coming back and improve the survival in patients with colon cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of following a low or medium glycemic load diet in patients with stage I-III (local-regional) colon cancer. SECONDARY OBJECTIVES: I. To determine patient-reported acceptability of diet. II. To determine nutritionist resources utilized. III. To evaluate the effect of lowering dietary glycemic load on body mass index (BMI), lipid metabolism and pro-oncogenic intermediaries of cellular metabolism. OUTLINE: Patients are sequentially enrolled in 1 of 4 possible cohorts as needed based on the feasibility of the prior cohort. COHORT 1: Patients follow a low glycemic load diet with standard dietary intervention (contact with nutritionist in person every 2 weeks with phone contact on the alternating weeks) for 12 weeks. COHORT 2: Patients follow a low glycemic load diet with intensified dietary intervention (contact with nutritionist in person every week) for 12 weeks. COHORT 3: Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks. COHORT 4: Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
- •Patients must regularly consume a diet with a glycemic load \> 150 as estimated through the 3 day food recall
- •Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
Exclusion Criteria
- •Current participation in an intervention targeting diet or exercise
Outcomes
Primary Outcomes
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
Time Frame: Up to week 12
This compliance rate will be determined through conducting a 24 hour telephone recall, every 2 weeks at random and calculating the glycemic load. For each dose cohort, the number and percentage of patients who are compliant will be summarized, with 90% confidence interval that accounts for the two-stage design.
Secondary Outcomes
- Hours of nutritionist time per week(Up to 12 weeks)
- Food acceptability score(Up to 12 weeks)